NDAORALTABLET, EXTENDED RELEASE
Approved
Feb 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XELJANZ XR (tofacitinib) is an oral, extended-release small-molecule JAK inhibitor approved by the FDA on February 23, 2016. The product is indicated for inflammatory and autoimmune conditions, functioning as a selective inhibitor of Janus kinase enzymes. As an oral therapy with convenient once-daily dosing, it offers an alternative to injectable biologics for patients requiring systemic immunosuppression.
$0.6BPart D
8.4 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis
Started Apr 2025
3 enrolled
Atopic Dermatitis (AD)
Efficacy and Safety of Tofacitinib in Refractory Blau Syndrome
Started Oct 2024
30 enrolled
Blau Syndrome
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
Started Jun 2024
65 enrolled
Ulcerative Colitis
A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis
Started May 2024
21,340 enrolled
Rheumatoid Arthritis
An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU)
Started Jan 2024
104 enrolled
Ulcerative Colitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.